STA Pharmaceutical Co., Ltd., (WuXi STA), a subsidiary of WuXi AppTec, completed the pre-approval inspection (PAI) for two APIs from the US Food and Drug Administration (FDA) with no Form 483s issued.
The FDA inspection is the first for the Changzhou facility, according to the contract development and manufacturing organization (CDMO).
WuXi STA has also passed FDA inspections at its API and advanced intermediate manufacturing facility in Shanghai, Jinshan as well as its drug product manufacturing facility in Shanghai, Waigaoqiao Free Trade Zone.
According to the company, WuXi STA is the first CMC platform in China to pass FDA inspection for new chemical entities, including both APIs and drug product.
The CDMO says it is also the country’s first to be approved to supply APIs and GMP intermediates for branded commercial drugs by regulatory agencies in the US, China, EU, Canada, Switzerland, Australia, and New Zealand.
The Changzhou facility was opened in early 2016 and currently employs more than 1,000 people. This number is expected to increase by more than 300 as the company adds seven multi-functional plants within the next five years, according to the CDMO.